Trial Outcomes & Findings for Subcostal TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Donor Nephrectomy Patients: A Prospective Study (NCT NCT02287623)

NCT ID: NCT02287623

Last Updated: 2023-04-10

Results Overview

This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: 48-72 hours after injection
• Results posted on: 2023-04-10

Participant Flow

Participant milestones

Measure	Liposomal Bupivacaine TAP Patients will receive a TAP block with liposomal bupivacaine liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine in the preoperative area before the kidney donation. This occurred under ultrasound guidance with the patient sedated. the patient received 30 mL total per tap. Each TAP consisted of 10 mL of liposomal bupivacaine and 20 mL of normal saline.	Bupivacaine TAP Patients will receive a TAP block with bupivacaine bupivacaine: patients will receive a tap with bupivacaine in the preoperative area before the kidney donation. This occurred under ultrasound guidance with the patient sedated. the patient received 30 mL total per tap. Each TAP consisted of 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	29
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Liposomal Bupivacaine TAP Patients will receive a TAP block with liposomal bupivacaine liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine in the preoperative area before the kidney donation. This occurred under ultrasound guidance with the patient sedated. the patient received 30 mL total per tap. Each TAP consisted of 10 mL of liposomal bupivacaine and 20 mL of normal saline.	Bupivacaine TAP Patients will receive a TAP block with bupivacaine bupivacaine: patients will receive a tap with bupivacaine in the preoperative area before the kidney donation. This occurred under ultrasound guidance with the patient sedated. the patient received 30 mL total per tap. Each TAP consisted of 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine.
Overall Study Protocol Violation	0	1

Baseline Characteristics

Subcostal TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Donor Nephrectomy Patients: A Prospective Study

Baseline characteristics by cohort

Measure	Liposomal Bupivacaine TAP n=30 Participants Patients will receive a TAP block with liposomal bupivacaine liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine	Bupivacaine TAP n=29 Participants Patients will receive a TAP block with bupivacaine bupivacaine: patients will receive a tap with bupivacaine	Total n=59 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=93 Participants	28 Participants n=4 Participants	57 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Sex: Female, Male Female	16 Participants n=93 Participants	19 Participants n=4 Participants	35 Participants n=27 Participants
Sex: Female, Male Male	14 Participants n=93 Participants	10 Participants n=4 Participants	24 Participants n=27 Participants
Region of Enrollment United States	30 participants n=93 Participants	29 participants n=4 Participants	59 participants n=27 Participants
weight	78.7 kilograms STANDARD_DEVIATION 12.3 • n=93 Participants	75.5 kilograms STANDARD_DEVIATION 15.5 • n=4 Participants	77.1 kilograms STANDARD_DEVIATION 13.9 • n=27 Participants

PRIMARY outcome

Timeframe: 48-72 hours after injection

This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period.

Outcome measures

Measure	Liposomal Bupivacaine TAP n=30 Participants Patients will receive a TAP block with liposomal bupivacaine liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine	Bupivacaine TAP n=29 Participants Patients will receive a TAP block with bupivacaine bupivacaine: patients will receive a tap with bupivacaine
Numerical Rating Scale	5 scores on a scale Interval 3.0 to 7.0	3 scores on a scale Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: 48-72 hours

Outcome measures

Measure	Liposomal Bupivacaine TAP n=30 Participants Patients will receive a TAP block with liposomal bupivacaine liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine	Bupivacaine TAP n=29 Participants Patients will receive a TAP block with bupivacaine bupivacaine: patients will receive a tap with bupivacaine
Post Operative Opioid Use	70 micrograms of fentanyl equivalents Interval 30.0 to 170.0	170 micrograms of fentanyl equivalents Interval 65.0 to 250.0

SECONDARY outcome

Timeframe: 0-72 hours

Outcome measures

Measure	Liposomal Bupivacaine TAP n=30 Participants Patients will receive a TAP block with liposomal bupivacaine liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine	Bupivacaine TAP n=29 Participants Patients will receive a TAP block with bupivacaine bupivacaine: patients will receive a tap with bupivacaine
Number of Patients With Post Operative Nausea/Vomiting	7 participants	15 participants

SECONDARY outcome

Timeframe: up to 30 days after surgery

Outcome measures

Measure	Liposomal Bupivacaine TAP n=30 Participants Patients will receive a TAP block with liposomal bupivacaine liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine	Bupivacaine TAP n=29 Participants Patients will receive a TAP block with bupivacaine bupivacaine: patients will receive a tap with bupivacaine
Post Operative Length of Stay	67.7 HOURS Interval 55.4 to 77.8	78.1 HOURS Interval 62.8 to 82.3

SECONDARY outcome

Timeframe: 24-48 hours

Use of opioids during 24-48 hours after surgery

Outcome measures

Measure	Liposomal Bupivacaine TAP n=30 Participants Patients will receive a TAP block with liposomal bupivacaine liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine	Bupivacaine TAP n=29 Participants Patients will receive a TAP block with bupivacaine bupivacaine: patients will receive a tap with bupivacaine
Postoperative Opioid Use	190 Micrograms of fentanyl equivalents Interval 100.0 to 335.0	240 Micrograms of fentanyl equivalents Interval 125.0 to 375.0

SECONDARY outcome

Timeframe: 0-24 hours

Post operative opioid use from 0-24 hours after surgery.

Outcome measures

Measure	Liposomal Bupivacaine TAP n=30 Participants Patients will receive a TAP block with liposomal bupivacaine liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine	Bupivacaine TAP n=29 Participants Patients will receive a TAP block with bupivacaine bupivacaine: patients will receive a tap with bupivacaine
Post Operative Opioid Use	160 micrograms of fentanyl equivalents Interval 107.5 to 322.5	230 micrograms of fentanyl equivalents Interval 100.0 to 315.0

Adverse Events

Liposomal Bupivacaine TAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupivacaine TAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jacob Hutchins

University of Minnesota

Phone: 612-624-9990

Email: hutc0079@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place